Who are your Interested Parties
What are the external and internal issues affecting the strategic direction of the organization (SWOT)
Understand the needs and expectations of those interested parties

and so on (according to the standard section 4.0)

Doing this is foundational to determining the scope of the QMS and what processes are part of the QMS etc. and will need to collaboration of the leadership team.

I understand that - from your other post - you have been tasked with getting your organization ISO compliant etc. However, if you "go it alone" it will bite you later on. It's not what the standard's intention is, especially since the role of a "management representative" as been removed, in part to spread the responsibility for the creation/implementation of the quality system across the members of management.

IMHO: I started with the organization's business plan, then we do the SWOT, then we create tables for interested parties and their issues. We reviewed the CAR log and have analyzed the repeated problems, or WEAKNESS of the SWOT. Then From the Company's Business Plan, we developed its own strategic plan. Listed all the interested parties (internal/external) and their requirements. That all constituted all the evidence in 4.1. In 4.2 we added another column to define the process that could meet the needs of interested parties. (4.1 + 4.2) were used as input to define the scope of our QMS (4.3). This was the biggest hurdle in setting up the QMS. Jennifer Kirley developed that Risk based planner which we used for our RBT. The information on the WEAKNESSES of the SWOT were entered as Risk in the Risk Based Planner. 4.4 is the SIPOC document which was linked into the Risk Based Planner. It's not perfect but according to the auditor we were in the right direction, needs improvement. Good Luck and hank you to the QFO Moderators.

Actually it's the other way around. Organizations use their context as input to their SWOT Analysis which in turn sets up their strategic directions/objectives. By ISO 9000:2015 definition, context of the organization is the "combination of internal and external issues that can have an effect on an organization’s approach to developing and achieving its objectives".

Thank you everyone for your input!!! I have been in multiple organizations that go through ISO Certifications but this is my first time setting up the initial certification for a site. I appreciate your help and I'm sure I'll have more questions for you guys. Thanks for your patience!

IMHO: I started with the organization's business plan, then we do the SWOT, then we create tables for interested parties and their issues. We reviewed the CAR log and have analyzed the repeated problems, or WEAKNESS of the SWOT. Then From the Company's Business Plan, we developed its own strategic plan. Listed all the interested parties (internal/external) and their requirements. That all constituted all the evidence in 4.1. In 4.2 we added another column to define the process that could meet the needs of interested parties. (4.1 + 4.2) were used as input to define the scope of our QMS (4.3). This was the biggest hurdle in setting up the QMS. Jennifer Kirley developed that Risk based planner which we used for our RBT. The information on the WEAKNESSES of the SWOT were entered as Risk in the Risk Based Planner. 4.4 is the SIPOC document which was linked into the Risk Based Planner. It's not perfect but according to the auditor we were in the right direction, needs improvement. Good Luck and hank you to the QFO Moderators.

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Hi MP480, could you share the formats, or procedures you used for that?
Thanks